HUMULINA 30:70 KWIKPEN 100 IU/ML SUSPENSION FOR INJECTION

Introduction

Package Leaflet: Information for the User

HUMULINA 30:70 KwikPen 100UI/ml injectable suspension

(Human insulin)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Humulina 30:70 KwikPen is and what it is used for
2. What you need to know before you use Humulina 30:70 KwikPen
3. How to use Humulina 30:70 KwikPen
4. Possible side effects
5. Storing Humulina 30:70 KwikPen
6. Contents of the pack and other information

1. What Humulina 30:70 KwikPen is and what it is used for

Humulina 30:70 KwikPen is a pre-filled pen that contains human insulin as the active substance, used to treat diabetes. You have diabetes if your pancreas does not produce enough insulin to control your blood sugar levels. Humulina 30:70 is used for long-term blood sugar control. It is a pre-mixed suspension of fast-acting and long-acting insulin. Its action is prolonged by the inclusion of protamine sulfate in the suspension.

Your doctor may tell you to use Humulina 30:70 KwikPen with another, slower-acting insulin. Each insulin has its own package leaflet that will inform you about this. Do not change your insulin unless your doctor tells you to. Be careful if you change your insulin. Each type of insulin has a different color and symbol on the packaging and pen so you can easily tell them apart.

2. What you need to know before you use Humulina 30:70 KwikPen

Humulina 30:70 in pre-filled pen is only intended for injection under the skin. Consult your doctor if you need to inject the insulin by another method.

Do not useHumulina 30:70 KwikPen:

• If you think you are starting to have hypoglycaemia (low blood sugar).Later in this leaflet, you will be told how to treat mild hypoglycaemia (see section 4, subsection A).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Humulina 30:70 KwikPen.

• If your blood sugar levels are well controlled with the insulin you are currently using, you may not feel the warning symptoms when your blood sugar levels fall too low. The warning signs are listed later in this leaflet. You must think carefully about when to take your meals, how often to exercise, and how intensely. You must also check your blood sugar levels very carefully by doing regular blood sugar tests.
• Some people who have had hypoglycaemia (low blood sugar) after changing from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you frequently have hypoglycaemia or have difficulty recognising the symptoms, consult your doctor.
• If your answer to any of the following questions is YES, tell your doctor, pharmacist, or nurse.
• • Have you been ill recently?
  • Do you have kidney or liver problems?
  • Are you doing more exercise than usual?
• If you drink alcohol, the amount of insulin you need may also change.
• You should also tell your doctor, pharmacist, or nurse if you plan to travel abroad. The time difference between countries may mean that your injections and meals have to be taken at different times than when you are at home.
• Some patients who have had type 2 diabetes for a long time and have heart problems or have had a previous stroke, treated with pioglitazone and insulin, have experienced heart failure. Tell your doctor as soon as possible if you have signs of heart failure, such as unusual shortness of breath or a rapid increase in weight or localised swelling (oedema).

Changes in the skin at the injection site:

You should rotate the injection site to avoid changes in the skin, such as lumps under the skin. Insulin may not work as well if you inject into a lumpy area (see How to use Humulina 30:70 KwikPen). Contact your doctor if you are currently injecting into a lumpy area before you start injecting into a different area. Your doctor may tell you to check your blood sugar levels more closely and adjust your insulin or the dose of your other anti-diabetic medications.

Using Humulina 30:70 KwikPen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your insulin needs may change if you are taking any of the following:

• Steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics (anti-diabetic medication),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta-2 stimulants (e.g. ritodrine, salbutamol, or terbutaline),
• beta-blockers,
• thiazides or certain antidepressants (monoamine oxidase inhibitors),
• danazol,
• certain angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor blockers.

Pregnancy, breast-feeding, and fertility

The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the last six months. If you are breast-feeding, you may need to adjust your insulin dose or diet.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Your ability to concentrate and react may be reduced if you are hypoglycaemic (have low blood sugar). Please be aware of this in all situations where you may put yourself and others at risk (e.g. driving a car or operating machinery). You should consult your doctor or nurse about driving if you:

• have frequent episodes of hypoglycaemia,
• have difficulty recognising the symptoms of hypoglycaemia or do not recognize them.

Humulina 30:70 contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially ‘sodium-free’.

3. How to use Humulina 30:70 KwikPen

Always check the name and type of insulin in the pack and on the label of the pre-filled pen when you get it from the pharmacy. Make sure you get the Humulina 30:70 KwikPen that your doctor has told you to use.

Follow the instructions for administering this medicine exactly as told by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again. To prevent possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dose

• Your doctor has told you which insulin to use, how much, when, and how often to inject. These instructions are only for you. Follow them exactly and attend your diabetes clinic regularly.
• If you change the type of insulin (e.g. from animal to human), you may need to use more or less than before. This may be just for the first injection or it may be a gradual change over several weeks or months.
• Humulina 30:70 in pre-filled pen is only intended for injection under the skin. Consult your doctor if you need to inject the insulin by another method.

Preparing Humulina 30:70 KwikPen

• Move the KwikPen between the palms of your hands 10 times and turn it upside down 10 times immediately before use to resuspend the insulin, until the contents appear uniformly cloudy or milky. If this does not happen, repeat the procedure until the contents are well mixed. The pen cartridges contain a glass ball to facilitate mixing. Do notshake vigorously to avoid creating foam, as this may interfere with the correct dose measurement. The pen cartridges should be examined frequently and not used if there are deposits of material or white solid particles stuck to the bottom or walls of the cartridge, giving it a frosted appearance. Check this each time you inject.

Getting the KwikPen ready to use (See User Manual)

• First, wash your hands.
• Read the instructions on how to use your KwikPen pre-filled insulin pen. Follow the instructions carefully. Here are some guidelines to follow.

• Use a new needle. (Needles are not included).

• Prime your KwikPen before each use. This ensures that the insulin comes out and any air bubbles are removed from your KwikPen. Small air bubbles may remain in the KwikPen, but they are not harmful. However, if the air bubble is too large, it may affect the accuracy of your dose.

InjectingHumulina 30:70

• Before injecting, clean the skin as you have been instructed. Inject under the skin, as you have been taught. Do notinject directly into a vein. After injection, keep the needle in the skin for 5 seconds to make sure you have taken the full dose. Do not rub the area where you have just injected. Make sure you inject at least 1 cm away from where you last injected and ‘rotate’ the injection sites as you have been taught.

After the injection

• Once you have injected, remove the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and prevent it from leaking out. It will also prevent air from entering the KwikPen and the needle from getting blocked. Do not share your needles or KwikPen.Put the cap back on the KwikPen.

Further injections

• Always use a new needle for each injection. Before each injection, remove any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing down. The scale on the cartridge shows approximately how many units are left.
• Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Dispose of the pen carefully; your pharmacist or nurse will tell you how to do this.

If you use moreHumulina 30:70than you should

If you use more Humulina 30:70 than you should, your blood sugar levels may become too low. Check your blood sugar levels (see section 4, subsection A).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to useHumulina 30:70 KwikPen

If you use less Humulina 30:70 than you should, your blood sugar levels may become too high. Check your blood sugar levels.Do not inject a double dose to make up for forgotten doses.

If you stop usingHumulina 30:70 KwikPen

If you use less Humulina 30:70 than you should, your blood sugar levels may become too high. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Human insulin may cause hypoglycemia (low blood sugar). See more information on hypoglycemia below in the subsection "Common Diabetes Problems".

Possible Adverse Effects

Systemic Allergy:it is very rare (affects less than 1 in 10,000 treated patients). The symptoms are as follows:

If you think you have this type of allergy to insulin with Humulina 30:70, inform your doctor immediately.

Local Allergy:it is frequent (affects less than 1 in 10 patients treated). In some patients, the injection site turns red, swells, or they may feel itching. Generally, these symptoms disappear in a few days or weeks. If this happens to you, consult your doctor.

Changes in the skin at the injection site:

If insulin is injected too frequently in the same place, the fatty tissue can shrink (lipoatrophy) or become thicker (lipohipertrophy) (it can affect up to 1 in 100 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is unknown). Insulin may not work very well if injected into a lumpy area. Change the injection site to help avoid these skin changes.

Edema (e.g., swelling of the arms, ankles, fluid retention) has been reported, especially at the start of insulin treatment or during a change in treatment to improve blood sugar control.

Common Diabetes Problems

• Hypoglycemia

Hypoglycemia (low blood sugar) means that there is not enough sugar in the blood. This can happen if:

• you use too much Humulina 30:70 or other insulin;
• you skip or delay meals or change your diet;
• you exercise or work too hard just before or after a meal;
• you have an infection or illness (especially diarrhea or vomiting);
• you have a change in your insulin needs; or
• you have liver or kidney problems that worsen.

Alcohol and some other medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually appear quickly and include the following:

Until you are sure to recognize the warning symptoms, avoid situations such as driving a car, as hypoglycemia can pose a risk to you or others.

Do not use Humulina 30:70 if you think you are starting to have hypoglycemia (low blood sugar).

If your blood sugar is low, take glucose tablets, sugar, or drink some sugary drink. Then take some fruit, cookies, or a snack as your doctor has indicated and rest. This will likely help you recover from mild hypoglycemia or a small overdose of insulin. If it worsens and your breathing becomes shallow and your skin pales, inform your doctor immediately. A glucagon injection can treat quite severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not respond to glucagon, go to the hospital. Ask your doctor for information about glucagon.

• Hyperglycemia and diabetic ketoacidosis.

Hyperglycemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycemia can be caused by:

• not taking your Humulina 30:70 or other insulin;
• taking less insulin than indicated by your doctor;
• eating much more than your diet allows; or
• fever, infection, or emotional stress.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms start slowly over several hours or days. The symptoms include the following:

Severe symptoms are heavy breathing and rapid pulse. Get medical help immediately.

If hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) are not treated, they can be very serious and cause headaches, nausea, vomiting, dehydration, loss of consciousness, coma, or even death.

Three simple stepsto avoid hypoglycemia or hyperglycemia are:

• Always have extra syringes and a vial of Humulina 30:70.
• Always carry something that identifies you as a diabetic patient.
• Always carry sugar with you.

• Illness

If you are ill, especially when you have nausea or vomiting, you may need to vary the amount of insulin you need. You need to continue with insulin even when you are not eating as you normally do. Perform urine or blood tests, follow the rules that you have been indicated to follow in these cases, and inform your doctor or nurse.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Humulina 30:70 KwikPen

Keep this medicine out of sight and reach of children.

Before the first use, store your Humulina 30:70 KwikPen in the refrigerator (between 2°C and 8°C). Do not freeze. Keep your Humulina 30:70 KwikPen "in use" at room temperature (below 30°C) for up to 28 days. Do not keep your pen "in use" in the refrigerator. Do not leave it near a heat source or in the sun.

Do not use this medicine after the expiration date that appears on the packaging and label. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that there are accumulations of material or white solid particles stuck to the bottom or walls of the cartridge, giving it a frosty appearance. Check it every time you inject.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofHumulina 30:70 KwikPen

• The active ingredientis human insulin. Human insulin is obtained in the laboratory by "recombinant DNA technology" and has the same structure as the natural hormone produced by the pancreas. Therefore, it is different from animal insulins. Humulina 30:70 is a premixed suspension that contains 30% dissolved insulin in water and 70% insulin with protamine sulfate.

• The other componentsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate 7H2O, zinc oxide, and water for injectable preparations. During manufacturing, sodium hydroxide and/or hydrochloric acid may have been used to adjust the acidity.

Appearance of the Product and Package Contents of Humulina 30:70KwikPen

Humulina 30:70 KwikPen 100 UI/ml injectable suspension is a white and sterile suspension, which contains 100 units of human insulin in each milliliter (100 UI/ml).

Each Humulina 30:70 KwikPen contains 300 units (3 milliliters).

Humulina 30:70 KwikPen is presented in a package of 5, 6, or 10 (2 x 5) units.

Only some package sizes may be marketed.

The Humulina 30:70 in your KwikPen is the same as the Humulina 30:70 in cartridges. In the KwikPen, the cartridge cannot be separated from the rest of the device. When the KwikPen is empty, it cannot be reused.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:Lilly S.A., Avda. de la Industria, nº 30. 28108 Alcobendas, Madrid. Spain.

Manufacturer:

Lilly France, S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

This medicine is authorized in the Member States of the European Economic Area with the following names:

Huminsulin “Lilly” Profil III KwikPen (Austria)

Humuline 30/70 KwikPen (Belgium, Luxembourg)

Huminsulin Profil III KwikPen (Germany)

Humulina 30:70 KwikPen (Spain)

Humulin M3 KwikPen (Greece, Ireland, Lithuania, Romania, Slovenia, United Kingdom)

Umuline profil 30 KwikPen 100 UI/ml (France)

Humulin M3 (30/70) KwikPen (Czech Republic, Slovakia)

Date of the last revision of this prospectus: August 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/